FDA.reportPublic FDA data

LORO HAND SANITIZER Anti-Bacterial Gel ETHYL ALCOHOL 70% 8 FL OZ (237 mL)

Manufacturer
Sun Hing Foods Inc
Effective date
2020-03-30
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-05-31 23:26:22

Label at a glance#

ProductLORO Hand Sanitizer
Active ingredientALCOHOL, ISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store below 110 Degree F (43 Degree C) May discolor certain fabrics or surfaces Manufacture By: Hanoi Biology Chemistry Group Corporation 252/57 Tay Son, Trung Liet Ward, Dong Da District, Hanoi, Vietnam

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (0.25% v/v).
  3. Isopropyl Alcohol (0.2% v/v).
  4. Sterile distilled water or boiled cold water (29% v/v).
  5. Acrylite Crosspolymer (0.5% v/v).
  6. Ginger Oil (0.05% v/v)

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Tehyl Alcohol 70% v/v, Isopropyl Alcohol 0.5%. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • Children under 6 years of age should be supervised when using LORO

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110 Degree F (43 Degree C)
  • May discolor certain fabrics or surfaces

Manufacture By:

Hanoi Biology Chemistry Group Corporation

252/57 Tay Son, Trung Liet Ward, Dong Da District,

Hanoi, Vietnam

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Acrylite Crosspolymer, Glycerine, Ginger Oil.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237mL237mL237 mL NDC: 78185-010-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78185-010-002022-01-28C16284748780-1d6a99b39-45b5-a426-e053-dadaa90af4c2LORO HAND SANITIZER Anti-Bacterial Gel ETHYL ALCOHOL 70% 8 FL OZ (237 mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78185-010-00LORO Hand Sanitizer237 mL in 1 BOTTLEGEL23712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78185-010LORO HAND SANITIZER (ETHYL ALCOHOL 70%) GEL [SUN HING FOODS INC]12Legacy NDC, 1 package rows20200831_ae2420f1-f91e-0b39-e053-2a95a90a2089.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78185-01078185-010-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GINGER OILSAS9Z1SVUKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ae2420f1-f910-0b39-e053-2a95a90a2089ae2420f1-f91e-0b39-e053-2a95a90a20892020-03-30WarningsExact identifier
spl id: ae2420f1-f910-0b39-e053-2a95a90a2089
spl set id: ae2420f1-f91e-0b39-e053-2a95a90a2089

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.